The Unified Intelligence Layer
for Regulated Manufacturing
Cognizio Core harmonizes LIMS, MES, ERP, SPC, SAP, and Veeva into a single AI-powered knowledge graph — deployed entirely within your own environment. Your regulated data stays under your control.
The Problem
Manufacturing Intelligence Exists in Silos.
Cognizio Core Ends That.
Regulated manufacturing organizations run on a patchwork of specialised systems that were never designed to talk to each other. LIMS holds lab results. MES holds batch records. ERP holds material lots. SPC holds process trends. Each system is a silo — and the intelligence that lives at their intersection is invisible.
Cognizio Core doesn't replace any of these systems. It sits above them as a central knowledge layer — connecting, harmonizing, and reasoning across all of them simultaneously to produce a single, authoritative view of your operation.
Platform Architecture
Four Pillars of Operational Intelligence
Cognizio Core is built on four architectural pillars that together deliver a complete operational intelligence capability for regulated manufacturing.
Knowledge Graph Platform
Cognizio Core builds a living knowledge graph across every connected system — mapping relationships between batches, materials, process parameters, results, equipment, and deviations. Query any node. Traverse any relationship. At any scale.
- Cross-system entity resolution and relationship mapping
- Queryable in natural language via AI agents
- Full batch genealogy and traceability across the supply chain
- Incrementally enriched as new data arrives
Harmonized Enterprise Data Model
Fragmented systems speak different languages. Cognizio Core's harmonized data model resolves semantic inconsistencies across LIMS, MES, ERP, and SAP — creating one consistent, validated ontology with system-specific configuration layers for each connected platform.
- Pre-built ontology and connector configurations for LIMS, MES, ERP, SAP, Veeva, and OSIsoft PI
- Semantic reconciliation across inconsistent data schemas
- Vendor-neutral — works with any combination of systems
- Extensible model for custom data sources and legacy systems
AI Orchestration Layer
Coordinated, purpose-built AI agents — Quality, Process, Compliance, and Investigation — that reason across the unified knowledge graph simultaneously. Not a generic chatbot. An orchestrated intelligence layer designed for regulated manufacturing.
- Multi-agent orchestration across all connected data sources
- Contextualised, cross-system answers in natural language
- Structured outputs for quality reviews, batch release, and investigations
- Configurable agent workflows for your specific processes
Single Source of Truth
Every question your quality, manufacturing, and regulatory teams ask — answered from one consistent, governed intelligence layer. All processing runs within your environment. Your data, your infrastructure, your control.
- Unified view across all manufacturing sites and systems
- Version-controlled data lineage and provenance
- GxP-aware audit trails on every query and output
- Consistent data for regulatory submissions and inspections
Deployment Architecture
Your Environment. Your Data.
Always.
Cognizio Core is licensed software delivered as a containerized stack — deployed entirely within your infrastructure. Regulated data never leaves your environment, satisfying 21 CFR Part 11 data residency requirements. No shared cloud. No multi-tenancy. No data egress.
Microsoft Azure
Azure Kubernetes Service
Native AKS deployment with Helm charts and Terraform modules. Integrates with Azure AD, Key Vault, and Defender for Cloud.
Amazon Web Services
Elastic Kubernetes Service
EKS-optimized container manifests. VPC-isolated architecture. Compatible with IAM, Secrets Manager, and GuardDuty.
Google Cloud Platform
Google Kubernetes Engine
GKE deployment with Workload Identity Federation, Cloud KMS key management, and Binary Authorization.
On-Premise
Private Data Center
Air-gapped and dark-site compatible. Bare-metal or VMware Kubernetes. No internet connectivity required.
Container Architecture & IaC
- Docker container images, versioned and digitally signed
- Kubernetes orchestration — Helm charts and Kustomize overlays
- Terraform IaC modules for Azure, AWS, and GCP provisioning
- System connectors with ontology layer: LIMS, MES, ERP, SAP S/4HANA, Veeva Vault, OSIsoft PI
- Configuration and ontology mapping tailored per connected system
- Validation documentation package (IQ/OQ/PQ support materials)
- Incremental connector updates and patches delivered within the annual license
Platform License Model
Full platform access including all modules, AI agents, and system connectors. Includes all software updates, patches, and new connectors as they are released throughout the license term.
Covers environment deployment, system connector setup, ontology mapping for each connected system, integration testing, and validation support documentation.
Named support relationship with defined response tiers, priority hotfixes, architectural guidance, and periodic platform review sessions.
How It Works
A Non-Invasive Intelligence Layer
Cognizio Core connects above your existing systems. No rip-and-replace. No data migration. Your systems stay in place — Cognizio Core harmonizes and reasons across them all, within your environment.
See Cognizio Core in Action
Explore pre-built scenarios: batch release readiness, root cause analysis, CAPA tracking, and yield driver analysis — all answered from a unified manufacturing knowledge graph.
Launch the Interactive DemoEnterprise-Grade
Built for Scale. Designed for Regulated Environments.
Private Deployment
Docker and Kubernetes container stack deployed within your environment — Azure, AWS, GCP, or on-premise. Full IaC deployment scripts included. No shared cloud infrastructure. No multi-tenancy.
Data Sovereignty
Regulated data never leaves your infrastructure. All AI reasoning and data processing runs within your controlled environment. No data egress. No third-party data access.
21 CFR Part 11 Aligned
Data integrity principles are foundational — not layered on top. Every query, every AI output, and every action carries a GxP-defensible audit trail. Annex 11 aware.
Multi-Site Scalability
Deploy across a single facility or a global manufacturing network. The containerized architecture scales horizontally without re-engineering.
Use Cases
Intelligence Across Every Function
Cognizio Core delivers value wherever fragmented manufacturing data creates delay, risk, or missed insight.
Quality Review Support
Annual product reviews, batch disposition, and lot release decisions synthesised from every connected system in minutes.
Deviation Investigations
AI-correlated root cause analysis across LIMS, MES, ERP, and SPC — uncovering relationships no analyst could find manually.
Batch Genealogy & Traceability
Full forward and backward traceability from raw material supplier lot to finished product, across all connected systems.
Predictive Quality Alerts
AI agents monitoring process trends in real time, surfacing early deviation signals before they become non-conformances.
Regulatory Readiness
Inspection-ready summaries, data lineage reports, and GxP-compliant documentation generated on demand.
Process Intelligence
Multivariate yield and quality driver analysis across hundreds of batches — identifying parameters that drive outcomes at scale.
Ready to Deploy Cognizio Core?
Speak with our team about connecting your manufacturing systems, configuring the knowledge graph for your environment, and accelerating time-to-insight.